Duns Number:784143778
Device Description: The Calcitonin ELISA is intended for use in the quantitative determination of Calcitonin i The Calcitonin ELISA is intended for use in the quantitative determination of Calcitonin in human serum.
Catalog Number
21-CALHU-E01
Brand Name
Calcitonin ELISA
Version/Model Number
21-CALHU-E01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K982491
Product Code
JKR
Product Code Name
Radioimmunoassay, Calcitonin
Public Device Record Key
548ced1d-ea94-43a5-a3fb-79635d379c87
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 03, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |